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Study on Monitoring Anticoagulant Therapy with Rivaroxaban and Warfarin in Patients with Acute Coronary Syndrome and Atrial Fibrillation

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the management of anticoagulant therapy in patients who have experienced an Acute Coronary Syndrome and have developed a new condition called Atrial Fibrillation. These are heart-related conditions where the blood flow to the heart is reduced, and the heart beats irregularly. The study will use two medications: Xarelto (rivaroxaban) and Coumadine (warfarin sodium), which are both used to prevent blood clots.

The purpose of the study is to determine if using an implantable device to monitor heart activity and guide anticoagulant treatment is safer in terms of reducing bleeding events compared to the standard approach. The study will involve the use of a small device placed inside the body that can send heart activity data to doctors remotely. This will help in deciding the best way to manage the anticoagulant treatment.

Participants in the study will be monitored over a period of two years. During this time, the occurrence of any bleeding events and other heart-related events will be recorded. The study aims to provide insights into whether this new method of monitoring and treatment can improve safety and outcomes for patients with these heart conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Eligibility is confirmed based on criteria such as age (18 or older), hospitalization for acute coronary syndrome, and presence of atrial fibrillation during hospitalization.
A CHA2DS2-VASc score is used to assess risk, requiring a score of 1 or more for men and 2 or more for women.
Ablation of atrial fibrillation must be completed before joining the study, either spontaneously or through treatment.
Coronary angioplasty with stenting is required during hospitalization.
Step 2
Treatment initiation
Participants receive anticoagulant therapy monitored by an implantable device with telecardiology.
The treatment includes Xarelto (rivaroxaban) 10 mg film-coated tablets and COUMADINE (warfarin sodium) 5 mg tablets, both taken orally.
The objective is to determine if this approach is safer in terms of bleeding events compared to standard treatment based on the CHA2DS2-VASc score.
Step 3
Monitoring and follow-up
Participants are monitored remotely using data from the implantable device.
The primary endpoint is the occurrence of a bleeding event during the 2-year follow-up, defined by a score of 2 or more on the BARC scale.
Secondary endpoints include the occurrence of events defined by the MACCE indicator and ischemic events such as cardiovascular death, stroke, systemic embolism, non-fatal infarction, and need for revascularization.
Step 4
Completion
The study is expected to conclude by February 2, 2026.
Participants will have completed a 2-year follow-up period to assess the safety and effectiveness of the treatment.

Who can join the trial?

7 criteria

Patients must be **18 years or older**.
Must have been hospitalized for **acute coronary syndrome**. This is a condition where the blood supply to the heart is suddenly blocked.
Must have **atrial fibrillation** either when arriving at the hospital or at any time during the hospital stay. Atrial fibrillation is a condition where the heart beats irregularly and often too fast.
Must not have any known history of **arrhythmia** before. Arrhythmia is an irregular heartbeat.
Must have a **CHA2DS2-VASc score** of 1 or more for men and 2 or more for women. This score helps to assess the risk of stroke in people with atrial fibrillation.
Must have had an **ablation** for atrial fibrillation before joining the study. Ablation is a procedure to correct heart rhythm problems.
Must have undergone **coronary angioplasty with stenting** during the hospital stay. This is a procedure to open blocked heart arteries.

Who cannot join the trial?

4 criteria

Patients who are not experiencing atrial fibrillation (a condition where the heart beats irregularly) or acute coronary syndrome (a range of conditions associated with sudden, reduced blood flow to the heart) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who do not meet the specific health conditions required for the study cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier De Pau
Pau, France
Verified
Centre Hospitalier De Perigueux
Perigueux, France
Verified
Centre Hospitalier Universitaire De Montpellier
Montpellier, France

Trial locations

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Investigated drugs

Anticoagulant Therapy
is used to prevent blood clots in patients who have experienced an acute coronary syndrome (ACS) and have developed a new type of irregular heartbeat called atrial fibrillation (AF). This therapy helps reduce the risk of stroke and other complications by thinning the blood and preventing clots from forming.
Implantable Holter with Remote Monitoring
is a small device placed under the skin that continuously records the heart's electrical activity. It allows doctors to monitor the heart rhythm remotely, providing real-time data to help manage and adjust the anticoagulant therapy more safely and effectively.

What is already known about the treatment

Warfarin – Warfarin is an oral medication used to prevent blood clots in conditions like atrial fibrillation and acute coronary syndrome. It is well-established in medical literature as an anticoagulant, helping to reduce the risk of stroke and heart attack by thinning the blood. Warfarin works by inhibiting vitamin K-dependent clotting factors, which are essential for blood clot formation. It is classified as a vitamin K antagonist and requires regular blood tests to ensure the correct dosage and minimize the risk of bleeding.

Investigated diseases

Atrial Fibrillation
Atrial fibrillation is a common heart rhythm disorder where the heart's upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and may cause symptoms like palpitations, fatigue, and shortness of breath. Over time, the irregular heartbeat can lead to complications such as blood clots, which may increase the risk of stroke. The condition can be persistent or occur in episodes, and its severity can vary among individuals. It often requires monitoring and management to prevent complications.
Acute Coronary Syndrome
Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It includes situations such as heart attacks and unstable angina. Symptoms often include chest pain or discomfort, which may spread to the shoulders, arms, neck, or jaw. The condition occurs when a coronary artery is blocked or severely narrowed, leading to damage to the heart muscle. It requires immediate medical attention to restore blood flow and minimize heart damage.